Demonstration of equivalence can streamline the medical device clinical evaluation process easily, as it allows manufacturers to rely on existing data rather than conducting new clinical studies. However, it’s important to note that this process is highly difficult and requires careful documentation and analysis by an expert team like I3CGLOBAL.
The below document includes details of the equivalent device and sufficient proof if a claim for equivalency is made. This section is concise and shall include:
• The equivalent device name, manufacturer name, models, sizes, software versions, accessories, etc.
• Relationship to the device under evaluation.
• Regulatory status of the equivalent device. If it is not CE-marked, justification should be given for using such a device as an equivalent.
• Justification for selecting the device as equivalent using a description of relevant clinical, biological and technical characteristics should be demonstrated.
• Provide a conclusion stating that equivalence is demonstrated, and the differences (if any) are not expected to affect the clinical performance and clinical safety of the device under evaluation.
Identification of Pertinent Data
The section should include information regarding the identification of relevant data generated for a device such as clinical investigations, PMS/PMCF data and details of pre-clinical studies. Clinical data generated from the scientific literature about the equivalent or similar device are also identified as relevant information.
Data generated and held by the manufacturer.
This section shall include details of clinical investigations, if any, PMS, PMCF, complaints, details of field safety corrective action, other user reports, and relevant preclinical study data (bench test reports, verification and validation data).
Post Market Surveillance (PMS)
This section should include the purpose behind conducting PMS. It should include which PMS sources are considered while conducting PMS depending on risk related to the device. The result obtained after PMS and the conclusion of PMS should be included. Also, should include when and on which population the study was conducted.
PMS Outcome
The outcome of PMS shall be recorded in this section with reference of annexes of PMS reports
Post Market Clinical Follow-Up (PMCF)
This section should include the purpose behind conducting PMCF. It should include the method of PMCF, when and on which population and no. of subjects studied. The results and conclusion of PMCF should be annexed as PMCF outcomes.
PMCF outcome
The outcome of PMCF shall be annexed as the PMCF evaluation report and relevant records of PMCF.
Relevant Pre-clinical Studies
Details of the various preclinical tests shall be provided.
Biocompatibility Testing
Provide an explanation of the biocompatibility studies conducted and the results of the same with relevance to clinical significance. The Biological evaluation plan and reports summary with the evidence of the test reports should be annexed.
Bench Testing
The results obtained from any external laboratory or in-house and their evaluation in significance with clinical evaluation should be provided.
Electrical safety
The results obtained from any external laboratory or in-house and their evaluation in significance with clinical evaluation should be provided.
Software verification and validation
The results obtained from the verification and validation including the firmware validation and its evaluation in significance with clinical evaluation should be provided.
Data Retrieved from Literature
The section should include a summary and justification of the literature search strategy applied for retrieval of clinical data, including objectives, sources used, search questions, search terms, selection criteria applied to the output of the search, quality control measures, results, number and type of literature found to be pertinent. The Literature search and review plan and report should be annexed.
Summary and Appraisal of Clinical Data
This section should summarize data generated and of scientific literature found to be pertinent including a summary of the studies or references, evaluation of their methodological quality, scientific validity of contents, relevance to the clinical evaluation, weighting attributed to the data, contents used (performance data, safety data, both) reasons for rejecting a study or document, reasons for rejecting some of its contents.
Analysis of Clinical Data
This section should include the analysis of clinical data about the safety, performance, risk-benefit –benefit and side effects of the device under evaluation.
The following sub-sections should be included with the summaries,
• Requirement for Safety
• Requirement on Acceptable Benefit/Risk
• Requirement on Performance
• Requirement on acceptability of side-effects
Clinical Evaluation Report Conclusion
• A clear statement concerning compliance with GSPR should be provided. Acceptability of the risk-benefit profile according to current knowledge/ the state of the art in the medical fields concerned and according to available medical alternatives.
• Summary on the adequacy of the information materials supplied whether the intended purpose and risk reduction measures are adequate and any discrepancies.
• Summary of the suitability of the device, including its IFU, for the intended users and usability aspects; any discrepancies. Adequacy of claims and their discrepancies.
• If there is consistency between the clinical data, the information materials, and the risk management documentation for the device under evaluation; discrepancies should be summarized.
• Description of residual risks and uncertainties or unanswered questions, whether these are acceptable for CE-marking, and how these should be followed during PMS.
• Details of ongoing PMS activities, e.g. in currently ongoing PMCF studies. Whether new or additional PMS activities, including PMCF studies, should be foreseen should be mentioned.
• It shall be updated with Vigilance as per Article 87 and Trend reporting as per Article 88.
• For class IIa, IIb and III medical devices the Periodic Safety Update Report (PSUR) must be prepared during the CER updating according to article 86.
Qualification of the Responsible Evaluators
The section should include information about evaluators’ training and/or experience in the relevant field. If the level of evaluator expertise is less than (degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task or different) this should be documented and duly justified.
Date of the Next Evaluation:
The frequency at which the clinical evaluation needs to be actively updated should be defined and justified. The following aspects should be considered:
• The significant risks of the device if high-risk or medium, high-risk target populations, severity of disease/ treatment challenges, duration of risk.
• Whether the device is well established, or the innovation is there, the current level of confidence in the evaluation of clinical performance and clinical safety of the device from the data available from clinical investigations, PMCF studies, registries or other systematic studies, reports of risk or adverse event rates under the vigilance system.
The clinical evaluation report is actively updated with When new information is received from PMS that has the potential to change the current evaluation; if no such information is received, then at least annually if the device carries significant risks or is not yet well established; or every 2 to 5 years. If the device is not expected to carry significant risks and is well established, a justification should be provided.
Dates and Signatures:
This section should include. Date of the clinical evaluation report. Statement from the evaluator/s about the contents of the report with dates, names and signatures of the evaluators. Final release with date, name and signature
Declaration of Interest and CV of Clinical Evaluator
The clinical evaluator should assess the degree to which the selected papers reflect the intended application and use of the device as per the labelling information. It is ensured that the evaluator knows of
· The device technology and its application,
· Specialist clinical expertise in the relevant medical speciality / Intended use of the device in question.
· Research methodology (clinical investigation design and biostatistics),
· Diagnosis and management of the conditions intended to be treated or diagnosed by the device, knowledge of medical alternatives, treatment standards and technology.
· The evaluators should have at least the following training and experience in the relevant field:
· Degree from higher education in the respective field and 5 years of documented professional experience; or
· 10 years of documented professional experience if a degree is not a prerequisite for a given task.
• The CV and Declaration of interest of the evaluated should be annexed.
Team I3CGLOBAL writers and consultants assist medical device manufacturers in the demonstration of equivalence and thereby completing a clinical evaluation report successfully as per article 61, MEDDEV 2.7.1 rev. 4 and MDCG 2020-5 guidance.
